Surgical instrument

ABSTRACT

The surgical instrument includes a distal tool, a rigid or flexible elongated shaft that supports the distal tool, and a proximal handle or control member, where the tool and the handle are coupled to the respective distal and proximal ends of the elongated shaft via distal and proximal bendable motion members. Actuation means extends between said distal and proximal members whereby any deflection of said control handle with respect to said elongated instrument shaft causes a corresponding bending of said distal motion member for control of said working member. A manually rotatable member is arranged adjacent to the control handle for manually rotating the instrument shaft and working member relative to the control handle.

RELATED APPLICATIONS

The present invention is a continuation-in-part of earlier filed U.S.application Ser. No. 10/822,081, filed on Apr. 12, 2004 now U.S. Pat.No. 7,147,650 which, in turn, claims priority to U.S. ProvisionalApplication Ser. No. 60/515,560, filed on Oct. 30, 2003. The presentapplication also claims priority to earlier filed U.S. ProvisionalApplication 60/671,189, filed on Apr. 14, 2005. This application is alsoa continuation of earlier filed U.S. application Ser. No. 11/242,642,filed on Oct. 3, 2005 now pending. The content of all of theaforementioned applications are hereby incorporated by reference hereinin their entirety.

TECHNICAL FIELD

The present invention relates in general to surgical instruments, andmore particularly to manually-operated surgical instruments that areintended for use in minimally invasive surgery or other forms ofsurgical procedures or techniques. The instrument described herein isfor a laparoscopic procedure, however, it is to be understood that theinstrument of the present invention can be used for a wide variety ofother procedures, including intraluminal procedures.

BACKGROUND OF THE INVENTION

Endoscopic and laparoscopic instruments currently available in themarket are extremely difficult to learn to operate and use, mainly dueto a lack of dexterity in their use. For instance, when using a typicallaparoscopic instrument during surgery, the orientation of the tool ofthe instrument is solely dictated by the locations of the target and theincision. These instruments generally function with a fulcrum effectusing the patients own incision area as the fulcrum. As a result, commontasks such as suturing, knotting and fine dissection have becomechallenging to master. Various laparoscopic instruments have beendeveloped over the years to overcome this deficiency, usually byproviding an extra articulation often controlled by a separatelydisposed control member for added control. However, even so theseinstruments still do not provide enough dexterity to allow the surgeonto perform common tasks such as suturing, particularly at anyarbitrarily selected orientation.

Accordingly, an object of the present invention is to provide animproved laparoscopic or endoscopic surgical instrument that allows thesurgeon to manipulate the tool end of the surgical instrument withgreater dexterity.

Another object of the present invention is to provide an improvedsurgical instrument that has a wide variety of applications, throughincisions, through natural body orifices or intraluminally.

SUMMARY OF THE INVENTION

To accomplish the foregoing and other objects and features of thisinvention, there is provided a surgical instrument that includes anelongated instrument shaft having proximal and distal ends; a workingmember disposed at the distal end of the instrument shaft; and a controlhandle disposed at the proximal end of the instrument shaft. The workingmember is coupled to the distal end of the elongated instrument shaftvia a distal motion member, while the control handle is coupled to theproximal end of the elongated instrument shaft via a proximal bendablemember. Actuation means extends between the distal and proximal motionmembers whereby any deflection of the control handle with respect to theelongated instrument shaft causes a corresponding bending of the distalmotion member for control of the working member. A manually rotatablemember is arranged adjacent the control handle for manually rotating theinstrument shaft and working member about their own axes.

In accordance with other aspects of the present invention the actuationmeans is constructed and arranged so that a motion of the handle causesa like direction motion of the working member, or alternatively theactuation means is constructed and arranged so that a motion of thehandle causes an opposite direction motion of the working member. Thedistal motion member may comprise a distal bendable member and theproximal bendable member is moveable in any direction. The handle maycomprise a handle housing and the manually rotatable member may comprisea rotation knob disposed at an open end of the housing. A portion of theproximal bendable member may be disposed in the rotation knob.

In accordance with still other aspects of the present invention, theproximal bendable member may comprise a unitary slotted structure havinga plurality of discs separated by slots. The surgical instrument mayalso include an actuation lever pivotally supported from the handle andan actuator cable intercoupled between the actuation lever and workingmember. The surgical instrument may also include a ratchet and pawlarrangement coupled to the lever, a slider within a housing of thehandle, a link for intercoupling the lever and slider and a releasebutton intercoupled to the ratchet. A pair of springs is provided, onesupported in the slider and coupled to the link and the other disposedbetween the slider and the handle housing.

In accordance with further aspects of the present invention the surgicalinstrument comprises an elongated instrument shaft having proximal anddistal ends; a working member coupled from the distal end of theinstrument shaft; a control handle disposed at the proximal end of theinstrument shaft; a distal motion means at the distal end of theinstrument shaft; a proximal motion means at the proximal end of theinstrument shaft; actuation means extending between the distal andproximal means whereby any deflection of the control handle with respectto the elongated instrument shaft causes a corresponding motion of thedistal motion means for control of the working member; and means formanually rotating the instrument shaft and working member relative tothe control handle.

In accordance with still further aspects of the present invention thedistal motion means comprises a distal bendable member and the proximalmotion means comprises a proximal bendable member that is moveable inany direction. The handle comprises a handle housing and said means formanually rotating comprises a rotation knob disposed at an open end ofthe housing. A portion of the proximal bendable member is disposed in ahollow of the rotation knob. The proximal bendable member comprises aunitary slotted structure having a plurality of discs separated by slotsand further including a plurality of ribs interconnecting adjacentdiscs, said ribs being disposed at intervals about the member of 90degrees or less.

In accordance with another aspect of the present invention there isprovided a surgical instrument comprising, an elongated instrument shafthaving proximal and distal ends; a working member disposed at the distalend of the instrument shaft; and a control handle disposed at theproximal end of the instrument shaft. The working member is coupled tothe distal end of the elongated instrument shaft via a distal motionmember while the control handle is coupled to the proximal end of theelongated instrument shaft via a proximal bendable member. Actuationmeans extends between the distal and proximal members whereby anydeflection of the control handle with respect to the elongatedinstrument shaft causes a corresponding bending of the distal motionmember for control of the working member. At least the proximal bendablemember may comprise a unitary slotted structure having a plurality ofdiscs separated by slots.

In accordance with another aspect of the present invention the distalmotion member also comprises a bendable member formed as a unitaryslotted structure having a plurality of discs separated by slots; theproximal bendable member includes a plurality of ribs interconnectingadjacent discs, said ribs being disposed at intervals about the memberof less than 90 degrees. The ribs are disposed at an interval on theorder of 60 degrees; and further including a manually rotatable memberarranged adjacent the control handle for manually rotating theinstrument shaft and working member relative to the control handle andabout their own axes.

A further embodiment of the invention is a surgical instrumentcomprising, an elongated instrument shaft having proximal and distalends; a tool disposed from the distal end of the instrument shaft andsupported extending along a distal tool axis; a control handle disposedfrom the proximal end of the instrument shaft; a distal bendable memberfor coupling the distal end of said elongated instrument shaft to thetool; a proximal bendable member for coupling the proximal end of theelongated instrument shaft to the handle; actuation means extendingbetween said distal and proximal bendable members for coupling motion ofthe proximal motion member to said distal motion member for controllingthe positioning of the tool; and a rotation knob adjacent the controlhandle and rotatable relative to the control handle for causing acorresponding rotation of the tool about the distal tool axis.

In accordance with other aspects of the present invention the proximalbendable member may support the rotation knob so that any rotationimparted to the knob causes a corresponding rotation of the proximalbendable member; the knob may have a cavity for receiving at least aportion of the proximal bendable member; the proximal bendable membermay be bendable into a curved configuration and is be fixedly securedwith the rotation knob; both the bendable members may be bendable into acurved configuration and any rotation of the rotation knob causes acorresponding rotation of the bendable members, instrument shaft andtool.

Another embodiment of the invention is a manually operated medicalinstrument having an instrument shaft that couples with an operatinghandle at a proximal end thereof and a tool at a distal end thereof. Theinstrument further comprises a proximal bendable member at the proximalend of the instrument shaft that is bendable into a curvedconfiguration, a distal bendable member at the distal end of theinstrument shaft that is bendable into a curved configuration, and oneor more actuating elements intercoupling the proximal and distalbendable members responsive to a manually initiated bending at theproximal bendable member to cause a corresponding bending into a curvedconfiguration of the distal bendable member so as to control, via thehandle, the positioning of the tool.

In accordance with still other aspects of the present invention thebendable members may be bendable in all directions; the bendable membersmay be bendable in any direction; the proximal bendable member may bemanipulated in any direction do that the distal bendable member iscontrolled in three dimensions; a rotation knob may be disposed betweenthe handle and proximal bendable member; the rotation knob may besupported to rotate the proximal bendable member therewith; the rotationof the rotation knob controls the tool for corresponding rotation abouta tool axis; the tool may be disposed from the distal bendable memberalong a longitudinal distal tool axis, the rotation of the rotation knobcausing a corresponding rotation of the tool about the distal tool axis;one or more actuating elements comprises a set of actuation cables andwherein at least one of the set is in tension while at least another onethereof is in relaxation; four cables may be disposed at 90 degreeintervals about the instrument shaft with two in tension and two inrelaxation during a bending and wherein the instrument shaft comprisesan elongated instrument shaft extending along a longitudinal axis andwherein the distal bendable member is disposed in-line with theelongated instrument shaft coupling a distal end of the elongatedinstrument shaft to the tool and wherein the proximal bendable member isdisposed in line with the elongated instrument shaft coupling a proximalend of the elongated instrument shaft via the rotation knob to thehandle.

Another embodiment of the invention is a surgical instrument comprising:an elongated instrument shaft having proximal and distal ends; a workingmember disposed from the distal end of the instrument shaft; and acontrol handle disposed from the proximal end of the instrument shaft. Adistal bendable member is capable of bending into a curvedconfiguration, the working member being coupled to the distal end of theelongated instrument shaft via the distal bendable member; a proximalbendable member is capable of bending into a curved configuration, thecontrol handle coupled to the proximal end of the elongated instrumentshaft via a proximal bendable member. A manually rotatable member isarranged adjacent the control handle and between the control handle andproximal bendable member. The rotatable member is adapted to be manuallyrotated to, in turn, rotate the instrument shaft, distal bendable memberand working member relative to the control handle. An actuation elementextends between the distal and proximal bendable members whereby anydeflection of the control handle with respect to the elongatedinstrument shaft causes a corresponding bending of the distal motionmember for control of the working member.

In accordance with other aspects of the present invention the rotatablemember comprises a rotation knob having a cavity for receiving at leasta portion of the proximal bendable member therein and at least a portionof the rotation knob is received by the handle in an open end of thehandle, the rotation knob having the proximal bendable member supportedtherein and in a fixed relative rotation with respect to the proximalbendable member. The working member may comprise a tool that issupported from the distal bendable member extending along a distal toolaxis and the rotatable member may comprise a rotation knob, the rotationof the rotation knob causing a rotation of the working member about thedistal tool axis. The rotation of the rotation knob rotates theinstrument shaft and distal bendable member, rotating the tool about thedistal tool axis while maintaining the orientation of the tool.

BRIEF DESCRIPTION OF THE DRAWINGS

It should be understood that the drawings are provided for the purposeof illustration only and are not intended to define the limits of thedisclosure. The foregoing and other objects and advantages of theembodiments described herein will become apparent with reference to thefollowing detailed description when taken in conjunction with theaccompanying drawings in which:

FIG. 1 is a perspective view of a preferred embodiment of the surgicalinstrument of the present invention;

FIGS. 2 a, 2 b and 2 c are sequential side views of one embodiment ofthe surgical instrument wherein the distal bendable member bends in thesame direction as the proximal bendable member;

FIGS. 3 a, 3 b and 3 c are sequential side views of another embodimentof the surgical instrument wherein the distal bendable member bends inthe opposite direction to the proximal bendable member;

FIG. 4 is a schematic side view of the surgical instrument depicted inFIGS. 1-3 illustrating the instrument extending through an incision andadapted to be controlled by a surgeon to roll the instrument tool aboutits longitudinal or Z axis;

FIG. 5 is a longitudinal cross-sectional side view of the surgicalinstrument of FIG. 1 with a handle position corresponding to the jawsbeing in a fully open position;

FIG. 6 is a longitudinal cross-sectional side view as depicted in FIG. 5further illustrating the jaws being closed upon a needle;

FIG. 7 is a fragmentary cross-sectional view of the handle assembly ofthe surgical instrument of FIG. 1 and further illustrating the jawactuation means exerting a pressure at the jaws;

FIG. 8 is a cross-sectional plan view taken along line 8-8 of FIG. 6 andillustrating the jaw actuation means exerting a pressure on the jaws;

FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 6 showingthe camming means for the moveable jaw;

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 6showing the flex cable anchors;

FIG. 11 is a cross-sectional view taken along line 11-11 of FIG. 6showing the distal flexible or bendable member and cables passingtherethrough;

FIG. 12 is a cross-sectional view taken along line 12-12 of FIG. 6showing the instrument shaft portion of the instrument and cablespassing therethrough;

FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. 6showing the cable transition from the instrument shaft to the proximalbendable member;

FIG. 14 is a cross-sectional view taken along line 14-14 of FIG. 6showing further details of the proximal bendable member and cablepassages;

FIG. 15 is a cross-sectional view taken along line 15-15 of FIG. 6showing the proximal end of the rotation member or knob;

FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. 6showing the ratchet and pawl locking action for the spring tensioning ofthe tool actuator cable;

FIG. 17 is a cross-sectional view taken along line 17-17 of FIG. 6showing the rotating barrel means to prevent torsional forces on thetool actuator cable;

FIG. 18 is a cross-sectional view taken along line 18-18 of FIG. 6showing the spring loading means for the tool actuator cable;

FIG. 19 is an exploded perspective view illustrating further details ofthe surgical instrument depicted in FIG. 1, particularly at the handleassembly;

FIG. 20 is a somewhat enlarged cross-sectional view of the distal end ofthe surgical instrument as taken along line 20-20 of FIG. 19;

FIG. 21 is an exploded perspective view of the distal end of thesurgical instrument as shown in FIG. 20;

FIG. 22 is a schematic side cross-sectional view of the instrument typedescribed in FIGS. 3 a-3 c including the cabling and actuation;

FIG. 23 is a schematic perspective view illustrating the cabling of FIG.22;

FIG. 24 is a schematic perspective view of an alternate cabling schemesuch as used in the embodiment of FIGS. 2 a-2 c; and

FIGS. 25-28 are sequential perspective schematic views illustrating thecable arrangement for different rotational positions.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The instrument of the present invention may be used to perform minimallyinvasive procedures. “Minimally invasive procedure,” refers herein to asurgical procedure in which a surgeon operates through small cut orincision, the small incision being used to access the operative site. Inone embodiment, the incision length ranges from 1 mm to 20 mm indiameter, preferably from 5 mm to 10 mm in diameter. This procedurecontrasts those procedures requiring a large cut to access the operativesite. Thus, the flexible instrument is preferably used for insertionthrough such small incisions and/or through a natural body lumen orcavity, so as to locate the instrument at an internal target site for aparticular surgical or medical procedure. The introduction of thesurgical instrument into the anatomy may also be by percutaneous orsurgical access to a lumen or vessel, or by introduction through anatural orifice in the anatomy.

In addition to use in a laparoscopic procedure, the instrument of thepresent invention may be used in a variety of other medical or surgicalprocedures including, but not limited to, colonoscopic, upper GI,arthroscopic, sinus, thorasic, transvaginal and cardiac procedures.Depending upon the particular procedure, the instrument shaft may berigid, semi-rigid or flexible.

Although reference is made herein to a “surgical instrument,” it iscontemplated that the principles of this invention also apply to othermedical instruments, not necessarily for surgery, and including, but notlimited to, such other implements as catheters, as well as diagnosticand therapeutic instruments and implements.

FIG. 1 is a perspective view of a preferred embodiment of the surgicalinstrument 10 of the present invention. In this surgical instrument boththe tool and handle motion members or bendable members are capable ofbending in any direction, thus enabling three dimensional toolpositioning. They are interconnected via cables in such a way that abending action at the proximal member provides a related bending at thedistal member. As will be described in further detail hereinafter, theproximal member is preferably larger than the distal member so as toprovide enhanced ergonomic control. FIGS. 2 a-2 c show a bending actionin which the distal bendable member bends in the same direction as theproximal bendable member. FIGS. 3 a-3 c show an alternate embodiment inwhich the bendable or flexible members are adapted to bend in oppositedirections. FIG. 23 is a schematic perspective view illustrating thecabling that corresponds to the action depicted in FIGS. 3 a-3 c. FIG.24 is a schematic perspective view illustrating the cabling thatcorresponds to the action depicted in FIGS. 2 a-2 c.

It should be noted that the amount of bending motion produced at thedistal bending member is determined by the dimension of the proximalbendable member in comparison to that of the distal bendable member. Inthe disclosed embodiment the proximal bendable member is approximatelythree times the diameter of the distal bendable member, and as a result,the motion produced at the distal bendable member is about three timesthe magnitude of the motion at the proximal bendable member. AlthoughFIGS. 2 and 3 show only the side view where only pitch motion isillustrated, it should be noted that the proximal bendable member can bebent in any direction controlling the distal bendable member to bend ineither the same or an opposite direction, but in the same plane. As aresult, as depicted in FIG. 4 the surgeon is able to roll theinstrument's tool about its longitudinal axis at any orientation simplyby rolling the axial rotation knob 24.

In this description reference is made to bendable members. These membersmay also be referred to as turnable members or flexible members. In thedescriptions set out herein, terms such as “bendable section,” “bendablesegment,” “bendable motion member,” or “turnable member” refer to anelement of the instrument that is controllably bendable in comparison toan element that is pivoted at a joint. The bendable elements of thepresent invention enable the fabrication of an instrument that can bendin any direction without any singularity and that is furthercharacterized by a ready capability to bend in any direction, all with asingle unitary or uni-body structure. A definition of these bendablemotion members is—an instrument element, formed either as a controllingmeans or a controlled means, and that is capable of being constrained bytension or compression forces to deviate from a straight line to acurved configuration without any sharp breaks or angularity.

Referring to FIG. 1, the surgical instrument 10 is comprised of a handle12 at the proximal end of the instrument, an elongated instrument shaft14 and a tool or end effector 16 disposed at the distal end of thesurgical instrument. In the disclosed embodiment the instrument shaft 14is rigid, usually of a metal material, although it may also beconstructed so as to be at least partially flexible or bendable. Fornormal laparoscopic procedures the instrument shaft 14 is usually rigid.For an example of a flexible instrument shaft used intraluminally referherein to FIGS. 14 and 15 of related U.S. application Ser. No.10/822,081, filed on Apr. 12, 2004 which is hereby incorporated byreference herein in its entirety.

In FIG. 1 the handle 12 is illustrated as comprised of two handle halves12A and 12B. A lever 22 is manipulatable by the surgeon for opening andclosing the end effector 16 at the distal end of the instrument shaft14. In FIG. 1 the end effector is illustrated as comprised of a movablejaw 44 and a fixed jaw 46. The rotation knob 24 at the proximal end ofthe instrument is used to rotate the entire instrument shaft and endeffector. This rotation is illustrated in FIG. 1 by the circular arrowR. Also note in FIG. 1 the illustration of a coordinate system expressedby the X-Y-Z axes. The roll of the instrument indicated by the arrow Ris about the Z axis. The Z axis corresponds to the longitudinal axis ofthe shaft 14 of the instrument 10. FIG. 1 also illustrates an adaptorcover 26 for partially retaining a portion of the proximal bendablemember 18. At the distal end of the instrument shaft 14, there isprovided the distal bendable member 20. In FIG. 1 this is illustrated atleast partially covered by the cover 98. The cover 98 may be a thinplastic or rubber flexible tube that readily deflects as the distalbendable member is actuated from the proximal bendable member. Forinstruments such as a needle holder or a suture assist device, thecompliant cover 98 is beneficial in preventing the suture from catchingwhile tying a knot. However, for other applications one may choose notto use the cover 98 so as to simplify the instrument and itsfabrication. Other components, such as the knob 24, cover 26 andbendable members are formed of a plastic material.

The instrument of the present invention is preferably constructed to bedisposable or alternatively resposable. Accordingly, to make theinstrument as inexpensively as possible most of the components are madeof a plastic material.

FIGS. 2 a-2 c depict one embodiment for the surgical instrument in whichthe handle and end effector are controlled to turn or bend in the samedirection. If the handle is turned upwardly then the tool turns upwardlyand vice-versa. FIG. 2 a shows the handle in a straight position and thecorresponding tool in a likewise straight position. FIG. 2 b illustratesthe handle end of the instrument having been moved upwardly in thedirection of arrow A. This causes a corresponding movement upwardly ofthe end effector 16 in the direction of arrow B. Similarly, FIG. 2 cillustrates the handle 12 being moved downwardly in the direction ofarrow C causing a corresponding movement downwardly of the end effector16 in the direction of arrow D. The bending forces depicted in FIGS. 2 band 2 c are imposed upon the proximal bendable member 18 and when thatis bent or turned, this causes a corresponding bending or turning of thedistal bendable member so as to orient the end effector. The bendingforces are imposed at the handle of the instrument by the surgeon. Also,although FIGS. 2 a-2 c only depict “up” and “down” movement essentiallyin the plane of the paper, it is understood that the handle can beactuated in any direction including planes in and out of the paper.

FIGS. 3 a-3 c depict a different embodiment of the surgical instrument.In this embodiment, the bending of the handle portion of the instrumentcauses an opposite direction bending of the end effector. In FIG. 3 athe handle is shown in a straight position and the end effector is alsoshown in a straight position. In FIG. 3 b the handle 12 has been movedupwardly in the direction of arrow E causing a corresponding movementdownwardly of the end effector 16 in the direction of arrow F. In FIG. 3c the handle 12 is shown being bent or turned to a downward position asillustrated by the arrow G. This causes a corresponding bending orturning up of the end effector 16 in the direction depicted by arrow H.

As with the embodiment of FIGS. 2 a-2 c, in the FIGS. 3 a-3 c thetranslation of the bending force at the handle end of the instrument istransferred to the distal end of the instrument. This occurs by way ofthe proximal bendable member 18 controlled by the user from the handle12 and, in turn, controlling the distal bendable member 12 which, inturn, controls the positioning and orientation of the end effector 16.Also, although FIGS. 3 a-3 c only depict “up” and “down” movementessentially in the plane of the paper, it is understood that the handlecan be actuated in any direction including planes in and out of thepaper.

FIG. 4 depicts the surgical instrument 10 in position, as may occurduring a surgical procedure. For example, the instrument may be used forlaparoscopic surgery through the abdominal wall 4. For this purposethere is provided an insertion site 6 at which there is disposed acannula or trocar 8. The shaft of the instrument 14 is adapted to passthrough the cannula 8 so as to dispose the distal end of the instrumentat an operative site. The end effector 16 is depicted in FIG. 4 at suchan operative site. FIG. 4 also depicts the rolling motion that can becarried out with the instrument of the present invention. This can occurby virtue of the rotation of the rotation knob 24 relative to the handle12. This is illustrated in FIG. 4 by the circular arrow R1. When therotation knob 24 is rotated, in either direction, this causes acorresponding rotation of the instrument shaft 14. This is depicted inFIG. 4 by the rotational arrow R2. This same motion also causes arotation of the end effector 16 as illustrated by the rotational arrowR3 in FIG. 4.

The combination of manipulation via the bendable members and therotation via the knob 24 provides a very precise and ergonomicallycomfortable degree of control for the surgeon. The instrument is adaptedto be held in a number of different ways in use. In one technique, theinstrument handle may be grasped so that the middle, ring and smallfingers are about the surface 12C while the thumb engages the lever 22and release button 96. The index finger may extend to engage therotation knob 24. In this way all manipulations can be easilycoordinated by the surgeon with one hand. The instrument may also begrasped in the following manner. The thumb may rest on the surface 12Cwhile the fingers grasp the lever 22. The index finger may manipulatethe knob 24. The thumb may also assist in manipulating the knob 24.

In the drawings a set of jaws is depicted, however, other tools ordevices may be readily adapted for use with the instrument of thepresent invention. These include, but are not limited to, cameras,detectors, optics, scope, fluid delivery devices, syringes, etc. Thetool may include a variety of articulated tools such as: jaws, scissors,graspers, needle holders, micro dissectors, staple appliers, tackers,suction irrigation tools and clip appliers. In addition, the tool mayinclude a non-articulated tool such as: a cutting blade, probe,irrigator, catheter or suction orifice.

Reference is now made to FIGS. 5-22 for further details of theinstrument 10 depicted in FIG. 1. The instrument that is depicted inFIGS. 5-22 is the embodiment illustrated in FIGS. 3 a-3 c. In thisparticular embodiment the cabling within the instrument shaft ismaintained in a straight configuration such as illustrated in FIG. 23.Alternate cabling is described in FIG. 24 corresponding to theembodiment of FIGS. 2 a-2 c.

As indicated previously, the end effector or tool 16 is actuated bymeans of the jaw actuation means 30 which is comprised primarily of theelongated lever 22. The lever 22 is supported from the housing at thelever pivot pin 23. Refer to FIGS. 5-7 and 19. The closing of the lever22 against the handle 12 acts upon the slider 28 which is used tocapture the very proximal end of the actuation cable 38. When the slider28 is in the position depicted in FIG. 5, it is noted that the endeffector jaws are fully open. When the slider is moved toward the rightas depicted in FIG. 6, then the jaws 44 and 46 are moved toward a closedposition. In FIG. 6 the jaws are illustrated as closing so as to grasp aneedle 45.

The instrument shaft 14 includes an outer shaft tube 32 that may beconstructed of a light weight metal material or may be a plasticmaterial. The proximal end of the tube 32 is received by the adaptorcover 26. The distal end of the tube 32 is secured to the distalbendable member 20. Refer to FIG. 21 for some further details of thedistal bendable member 20. Within the outer shaft tube 32 there isprovided a support tube 34 that is preferably constructed of a plasticmaterial. Tube 34 extends between the distal bendable or flexible member20 and the proximal bendable or flexible member 18. The jaw actuatorcable 38 extends within this support tube 34. The support tube 34, asdepicted in FIG. 21, supports along its length a plurality of spacers36. There may be five spacers disposed along the support tube 34. In theschematic diagram of FIG. 23 less than five are shown so as to simplifythe diagram. Each of the spacers 36 is preferably evenly spaced and eachis provided with diametric guide slots 37. In the embodiment disclosedherein there are four such guide slots disposed at 90 degree intervalsabout each spacer 36.

Refer also now to FIG. 21 for further details of the tool end of theinstrument. The end effector 16 is comprised of a pair of jaws 44 and46. As indicated previously these jaws may be used to grasp a needle 45or other item. The upper jaw 44 fits within a channel 47 in the lowerjaw 46. A pivot pin 48 is used between the jaws to enable rotationtherebetween. A translation pin 42 extends through the slot 50 of jaw 46and the slot 52 of jaw 44 and engages with the hole in the distal cableend connector 40. The connector 40 is secured to the very distal end ofthe jaw actuator cable 38 and is positioned within the channel 49 of thejaw 44. When the lever 22 is in its rest position, as depicted in FIG.5, the jaws are fully open. In that position the pin 42 is at a moredistal location maintaining the jaw in an open position. As the cable 38is pulled, such as to the right in FIG. 6, then the pin 42 moves to theright in the slots 50 and 52 causing the jaws 44 and 46 to pivot towarda closed position as depicted in FIG. 6.

FIG. 21 also depicts an end wall 54 of the jaw 46. One end of the distalbendable member 20 is urged against this end wall 54. The member 20 maybe secured to the wall 54 by an appropriate means. In the disclosedembodiment, the cabling tension itself of the instrument holds themembers together. On the end wall 54 there are disposed a pair ofanchors 56 and 58 for the flex control cables 100. FIG. 21 illustratesfour such cables 100 a, 100 b, 100 c and 100 d. The distal end of thedistal bendable member 20 is provided with pockets 59 for receiving theanchors 56 and 58. In this regard refer also to the cross-sectional viewof FIG. 20 for an illustration of the position of the anchors 56 and 58.The anchors 56 and 58 are firmly attached to the end wall 54. FIG. 20also illustrates the jaws closed with the translation pin 42 at theright end of the slots 50 and 52.

The jaw actuator cable 38 terminates at its respective ends at the endeffector and the rotation barrel 66 (see FIG. 6). Within each of thebendable sections or bendable members 18 and 20 there is provided aplastic tube. This includes a distal tube 60 and a proximal tube 62.Both of these tubes may be constructed of a plastic such aspolyethyletherkeytone (PEEK). The material of the tubes 60 and 62 issufficiently rigid to retain the cable 38 and yet is flexible enough sothat it can readily bend with the bending of the bendable members 18 and20. The tubes have a sufficient strength to receive and guide the cable,yet are flexible enough so that they will not kink or distort, and thuskeep the cable in a proper state for activation, and also defines afixed length for the cable. The tubes 60 and 62 are longitudinallystiff, but laterally flexible.

FIG. 7 illustrates the proximal tube 62 extending within the proximalbendable member 18 between the support tube 34 and the rotation shaft64. The jaw actuator cable 38 also extends through the rotation shaft64. Refer also to FIG. 19 for an illustration of the rotational shaft64. At either end of the shaft 64 is an E-ring 65 for securing therotational shaft 64 in place. FIG. 19 illustrates the shaft 64 extendingfrom the rotational knob 24 and the handle halves 12A and 12B that wraparound a part of the rotation knob 24. The opposite end E-rings 65engage respectively with the handle and rotational knob and retain therotational knob 24 in place relative to the handle 12, which, in turn,then retains the proximal bendable member in place relative to thehandle. FIG. 7 shows the E-ring 65 on the left being disposed between aninterior cavity of the knob 24 and a cavity in the proximal bendablemember 18. The E-ring 65 on the right in FIG. 7 is captured by thehandle 12.

The control of the end effector 16 is by means of the jaw actuator cable38. The very proximal end of the jaw actuator cable 38 is retained inthe rotational barrel 66. As illustrated, for example, in FIG. 7 thecable 38 is secured to the rotational barrel by means of a pair of setscrews 67. The rotational barrel 66 is supported within the slider 28.More particularly, the rotational barrel 66 is disposed within theslider pocket 68. Refer also to FIG. 19 for an illustration of thebarrel 66 and pocket 68. The slider 28 is also provided with a slot 69that extends from the pocket 68 and accommodates the link 70. The link70 is the main means for actuating the slider 28 and, in turn, theactuator cable 38 from the lever 22.

The actuation link 70 is supported at one end from the lever 22 by meansof the pivot pin 71. The pivot pin 71 is disposed within a slot of thelever 22 as is depicted in FIG. 19. The opposite end of the link 70 issupported at another pin, referred to herein as slider pin 72. The pin72 is retained for longitudinal movement in the slot 74 in the slider28. FIG. 7 shows the respective pins 71 and 72 at the opposite ends ofthe link 70. FIG. 7 also illustrates the slider pin 72 urged against theactuator spring 76. The spring 76 is disposed within a compartment ofthe slider 28. The opposite end of the actuator spring 76 is retained bymeans of a retaining pin 80 that is disposed in the bore 78 thataccommodates the spring 76. FIGS. 6, 7 and 19 also show the returnspring 82 which is disposed within a bore 84 in the handle foraccommodating the spring 82. One end of the spring 82 is urged againstan interior wall of the handle and the opposite end of the spring isurged against an end wall of the slider 28. The spring 76 is a strongerspring than the spring 82 so that the spring 82 compresses first as thelever 22 is activated. Additional motion of the lever then causes thespring 76 to compress as the item is grasped. This dual springarrangement prevents damage to the instrument cabling, particularly atthe distal end of the instrument due to excessive forces imposed by thelever action.

The lever 22 actuates the end effector as it is pressed toward thehandle body. The lever 22 operates with a ratchet and pawl arrangementwith the lever capable of being depressed in ratcheted increments. Thisratchet and pawl arrangement includes the ratchet 86 and pawl 88. Toaccommodate the ratchet 86, the slider 28 is provided with an end dishout or cut out 87, such as is illustrated in FIG. 5. The pawl 88depicted also in FIG. 19 is retained by the handle members 12A and 12B.In this regard in handle part 12A there is a pocket 89 for the pawl 88and in the handle part 12B there is provided a leg 89A for retaining thepawl. The ratchet 86 pivots at the pivot pin 90 and is provided with aseries of ratchet teeth that can hold the ratchet in successivepositions corresponding to successive degrees of closure of the endeffector. A torsion spring 92 is disposed partially about the pivot 90and urges the ratchet teeth into contact with the pawl 88 as illustratedin FIG. 7 in a fully closed position.

The ratchet and pawl arrangement also includes an integral release meansthat is usually engageable by the surgeons thumb. As depicted in FIG. 7,on one side of the pivot 90 there is the ratchet 86 and on the otherside of the pivot there is the arm 94. A release button 96 is formed atthe base of the arm 94. When a force is directed in the direction ofarrow M in FIG. 7 then this releases the ratchet and pawl arrangementand returns the lever 22 to its released position with the jaws fullyopened, as in FIG. 5.

Reference is now made to the cabling that extends between the proximaland distal bendable members. This cabling is provided so that anybending at the proximal bendable member is converted into acorresponding bending at the distal bendable member. The bendablemembers that are described herein enable bending in all directions. Inthe preferred embodiment described herein, the distal bendable member isapproximately ⅓ the diameter of the proximal bendable member asillustrated in FIG. 5. However, as indicated before other diameterrelationships can be used depending upon the particular use of theinstrument and the medical procedure in which it is being used.

The control between the proximal bendable member 18 and the distalflexible member 20 is carried out by means of the flex control cables100. There are four such cables identified, for example, in FIG. 21 ascables 100A, 100B, 100C and 100D. At the distal end of these cables, ashas been described hereinbefore, the cables connect to the anchors 56and 58 at the jaws. Cables 100 are retained at their proximal ends bycable end lugs 102. Four springs 104 are retained between these end lugs102 and a wall of the rotation knob 24. Refer to FIG. 19 for anillustration of the end lugs 102 and the springs 104. The springs 104tension or take up the slack on the cables. Between the bendablemembers, the cables 100 are guided by means of the slots 37 in thespacers 36 along the support tube 34. Refer also to FIGS. 23 and 24.Within the adaptor cover 26, the cables 100 extend through thetransition member 106. The cables then extend to a larger outer diameterlocus as they extend through the proximal bendable member as depicted inFIGS. 6 and 7. The stepped transition member 106 may be of metal and issecured to the end of tube 32.

FIG. 21 depicts the distal end of the instrument and, in particular, thedistal flexible member 20. This is in the form of a single piece slottedstructure comprised of alternating slots and discs. The discs aresupported from a central member defining the bore 120. FIGS. 21 and 22illustrate the discs 110 that define therebetween the annular slots 112.Between adjacent discs there are also provided connecting ribs 111.Clearance holes 114 are provided for receiving the cables 100. Theseclearance holes are provided in the ribs and discs. To align the distalflexible member with the shaft tube 32, there is provided an alignmenttab 116 on the distal bendable member 20 and a corresponding slot 118 inthe tube 32. One tab and slot arrangement is illustrated in FIG. 21,however, it is understood that more than one tab and slot may beprovided The distal bendable member 20 also has a central bore 120 forreceiving the aforementioned PEEK tube 60.

The proximal bendable member 18 is also constructed as a unitary oruni-body slotted structure including a series of flexible discs 130 thatdefine therebetween slots 132. A “unitary” or “uni-body” structure maybe defined as one that is constructed for use in a single piece and doesnot require assembly of parts. Connecting ribs 131 extend between thediscs. Clearance holes 134 are provided for accommodating the cables100. As with the distal bendable member, the proximal bendable memberalso includes alignment tabs 136 and corresponding slots (not shown) inthe rotation knob 24. The proximal bendable member 18 is also providedwith a central bore 140 for receiving the tube 62

Both of the bendable members preferably have a rib pattern in which theribs (111, 131) are disposed at a 60 degree variance from one rib to anadjacent rib. This has been found to provide an improved bending action.It was found that by having the ribs disposed at intervals of less than90 degrees therebetween improved bending was possible. The ribs may bedisposed at intervals of from about 35 degrees to about 75 degrees fromone rib to an adjacent one. By using an interval of less than 90 degreesthe ribs are more evenly distributed. As a result the bending motion ismore uniform at any orientation. In the present invention both of thebendable members may be made of a highly elastic polymer such as PEBAX(Polyether Block Amide), but could also be made from other elasticmaterials.

FIGS. 5-7 illustrate a sequence of operation of the surgical instrument,including in particular the tool actuation that is controlled by theactuation lever 22. In the illustrated example employing a pair of jaws,there is provided a dual spring arrangement (springs 76 and 82) thatenables the grasped item to be securely held by the jaws. Reference isnow made to FIG. 5 for an illustration of the surgical instrument inwhich the lever 22 is at its fully released (down) positioncorresponding to the jaws 44 and 46 being in a fully open position. Atany time the release button 96 may be depressed to move the lever 22 tothat position. In that position the springs 76 and 82 are in theirexpanded or relaxed position and the ratchet 86 is at its top end oftravel with the pawl engaging a top tooth of the ratchet.

The cross-sectional view of FIG. 6 illustrates the lever 22 beingdepressed further. This is illustrated by the arrow H in FIG. 6. Thedepression of the lever 22 causes a corresponding motion of the link 70.This motion imparts a force to the spring 72. However, spring 76 is astiffer spring than spring 82 and thus in the position illustrated inFIG. 6 the slider pin 72 is maintained to the left of the slot 74. Atthe position of FIG. 6 substantially only the larger diameter spring 82is compressed. This is illustrated by the arrow I. In this position itis also noted that the ratchet has now moved to a position approximatelymid-point of its teeth at ratchet 86 relative to the pawl 88. Thisaction represents the state where the jaws are just beginning to exert aforce on the needle. This is illustrated by the arrow J in FIG. 6,indicating movement of the jaws to a more closed position for graspingthe needle 45.

At the position illustrated in FIG. 6, the spring 82, having a smallerpoundage than the spring 76, compresses when the force on the lever isapproximately 3 to 4 pounds. In the position of FIG. 6, even though theneedle 45 has been grasped, the spring 76 is substantiallynon-compressed at that stage, but is pre-loaded from the spring 82.

Reference is now made to FIG. 7 for an illustration of the lever 22having been moved to a position in which the spring pressure imposes atightening of the item that is being grasped. In FIG. 7 the arrow Killustrates the further lever movement loading the spring pressure onthe jaws. This additional lever rotation causes the slider pin 72 toslide within the slot 74 further compressing the spring 76. This isillustrated in FIG. 7 by the arrow L. This imposes an additional forceon the slider 28 causing the actuator cable 38 to tightly close the jawsabout the needle 45. FIG. 7 also illustrates by the arrow M the releasesequence in which the button 96 may be pressed to release the ratchet 86from the pawl 88 and thereby return the lever arm 22 to the positionillustrated in FIG. 5.

Reference is now made to FIGS. 9-18. These figures are successivecross-sectional views taken from FIG. 6 and showing furthercross-sectional details of components of the surgical instrument. Thecross-sectional view of FIG. 8 is a longitudinal cross-sectionillustrating the top of the slider 28. The cross-sectional view of FIG.9 is taken at the jaws 44 and 46 and further illustrates the slide pin42 controlled to move in the slots 50 and 52 by engagement with thedistal cable end connector 40.

The cross-sectional view of FIG. 10 illustrates the anchors 56 and 58for the flexible cables as well as the tool actuator cable 38 disposedwithin the tube 60.

FIG. 11 is a cross-sectional view taken through the distal bendablemember 20. FIG. 11 also illustrates the actuator cable 38, tube 60 andthe position of the ribs 111. It is apparent from FIG. 11 that the ribs111 are disposed, from one to the other, at an angle of approximately 60degrees. These ribs are preferably disposed at an angle of less than 90degrees.

FIG. 12 is a cross-sectional view taken through the instrument shaft.This view illustrates the support tube 34 having the actuator cable 38therein. This view also illustrates the outer shaft tube 32 and the flexcontrol cables 100.

FIG. 13 is a cross-sectional view taken at the adaptor cover 26 wherethe control cables transition between the instrument shaft and theproximal bendable member 18. FIG. 13 illustrates the four flex controlcables 100A, 100B, 100C and 100D so transitioning. FIG. 13 alsoillustrates one of the spacers 36 with its associated guide slots.

FIG. 14 is a cross-sectional view taken directly through the proximalbendable member 18. This illustrates the disks 130 and theinterconnecting ribs 131. Clearance holes 134 are illustrated forreceiving the control cables 100. As with the distal bendable member,the proximal bendable member has its ribs disposed at 60 degreeintervals from one rib to the next. These ribs are preferably disposedat an angle of less than 90 degrees. The clearance holes 134 arepreferably diametrically disposed as illustrated in FIG. 14. FIG. 14also illustrates the angular relationship between the ribs as angle θ,and the interrelationship regarding the clearance holes as the angle β.The angle β is shown at 90 degrees.

FIG. 15 is a further cross-sectional view that is taken essentially atthe proximal end of the rotation knob 24. This illustrates the cable endlugs 102, the actuation cable 38 and the rotation shaft 64. It is alsonoted in FIG. 15 that the same arrows are used therein as previouslydescribed in connection with FIG. 4. Thus, in FIG. 15 the arrow R1indicates rotation of the knob 24 while the arrow R2 indicates rotationof the instrument shaft. The rotation knob 24, as illustrated, includesa plurality of indentations 24A. These are preferably arcuate as shownand define therebetween peaks 24B. This surface is configured so thatthe thumb of the user can readily rotate the knob 24 by engagement ofthe thumb with one or more of the knob indentations 24A.

The cross-sectional view of FIG. 16 illustrates the ratchet and pawllocking action for the spring tensioning of the actuator cable 38. FIG.16 illustrates the ratchet 86, the pawl 88, the release button 96, thetorsion spring 92, and the rotation shaft 64 with its associated E-ring65. FIG. 16 also illustrates the release button 96.

FIG. 17 is a cross-sectional view showing the rotating barrel means thatis used to prevent torsional forces on the actuator cable 38. The slider28 has a pocket 68 for accommodating the rotational barrel 66. FIG. 17also shows a set screw 67 for attaching the actuator cable 38 to therotational barrel 66.

Finally, the cross-sectional view of FIG. 18 shows further details ofthe spring loading means. This includes the spring 76, slider 28, lever22, and link 70.

Reference is now made to FIG. 22. FIG. 22 is a cross-sectional view thatfocuses on the proximal and distal bendable members particularly as tothe relationship between the bending angles that are preferred.Regarding the proximal bendable member 18, this is illustrated as beingbent through an angle B1. The distal bendable member 20 is illustratedas being bent through an angle B2. By way of example, the angle B1, ifat a 35 degree, corresponds with a distal bendable angle B2 ofapproximately 70 degrees. Thus, it can be seen that the difference indiameter between the bendable members enables a greater degree ofbending at the distal end for a corresponding bending at the proximalend. Although this illustrated diameter relationship for the bendablemembers is preferred, it should be understood that other variations maybe used, including the use of the same diameters at the proximal anddistal ends of the instrument or even using a larger diameter at thedistal end corresponding to a smaller diameter at the proximal end.

Reference is now made to the schematic diagrams of FIGS. 23 and 24. Theschematic diagram of FIG. 23 corresponds to the instrument motionsdepicted in FIGS. 3 a-3 c. The schematic diagram of FIG. 24 correspondsto the instrument motions depicted in FIGS. 2 a-2 c. In FIG. 23 theinstrument shaft 14 is illustrated as containing a series of spacers 36having associated guide slots 37 for positioning each of the controlcables 100. In this embodiment the control cables extend in a straightorientation while in FIG. 24 the control cables are twisted through180degrees.

In FIG. 23 at the distal end of the instrument, the control cables areidentified as cables 100A, 100B, 100C and 100D. At the proximal end ofthe instrument, the same cables are identified as cables 100A′, 100B′,100C′ and 100D′. This straight alignment of the cables results in arelationship between the proximal and distal bendable members asillustrated in FIGS. 3 a-3 c. In other words, when the handle end ismoved up the tool end moves down and vice versa. In the schematicdiagram of FIG. 24, the same number of spacers 36 may be employed. In anactual instrument that has been constructed five such spacers have beenused, although, for simplicity in FIGS. 23 and 24 only three spacers areshown. In the embodiment of FIG. 24 the control cables 100 are twisted180 degrees as they progress from one end of the instrument shaft to theother. Thus, for example, a proximal cable 100C′ at the proximal end ofthe instrument is twisted so that the cable 100C at the distal end ofthe instrument is displaced by 180 degrees. This creates a relatedbending between the proximal end distal ends of the instrument as isillustrated in FIGS. 2 a-2 c. In other words, when the handle end ismoved up the tool end moves up and vice versa.

Regardless of which embodiment is used, either the one in FIG. 23 or theone in FIG. 24, the actuator cable 38 operates in substantially the sameway. Operation of the lever 22 pulls the cable in a direction of arrow Iin FIG. 6, closing the end effector. Release of the lever moves thecable in the opposite direction. Both actions occurs in the normalposition of the instrument such as in FIG. 3 a or in other deflectedpositions such as in FIGS. 3 b and 3 c where the proximal bendablemember 18 controls the distal bendable member 20. In this regard, thecable 38 is preferably supported centrally in the instrument shaft aswell as in the bendable members as illustrated in the drawings herein.In this way, when a bending occurs there is no significant movementimparted to the cable 38 by the bending action. In other words, the endeffector actuation is de-coupled from the bending action.

The rotation of the knob 24 also occurs without effecting the bendingand tool actuation actions. This rotation action is also de-coupled fromthese other actions or motions. For example, rotation of the knob 24, inand of itself, does not effect tool actuation or bending actions.Regardless of the position of the lever 22 or the degree of bending atthe proximal bendable member, any rotation at the knob 24 imparts a likerotation to all of the components distal of the knob 24 including theinstrument shaft 14, the end effector 16 and the proximal and distalbendable members 18 and 20 while maintaining the orientation at thedistal end bendable section. As the components are rotated from the knob24, the cable 38 will rotate therewith. The rotating barrel means,namely the barrel 66, prevents torsional forces on the tool actuatorcable. The rotational barrel 66, which is secured to the very proximalend of the actuator cable 38, is rotatable within the slider 28 so thatthe cable readily rotates with the rotation of the knob 24. It is notedthat the direction of the bend (orientation) of the distal bendablemember is not effected by the rotation at the knob 24. This rotationsimply rotates the distal motion member on its own axis without changingorientation.

Another aspect of the surgical instrument of the present inventionrelates to the ease with which the surgeon can manipulate the instrumentin effectively performing a surgical procedure. The placement of therotation knob 24 in close proximity to the handle 12 and proximalbendable member 18 makes manipulation easier. It is advantageous to havea part of the proximal bendable member 18 disposed within a hollowcenter of the rotation knob 24 as is clearly shown in FIGS. 6 and 7. Thehollow area is formed by a tapered wall 25 (see FIGS. 7 and 22) thatenables bending or deflection of the proximal bendable member 18, suchas is illustrated in FIG. 22 where the proximal bendable member 18 is atone extreme of bending. The knob 24 is also shown rotationally supportedadjacent to the handle 12 so that it is in a convenient position for useby the surgeon.

The axial rotation knob 24 is rotatably mounted on the tube 64, which inturn is clamped to the handle body. As a result the axial rotation knobis able to freely rotate relative to the handle body, manipulated byeither the thumb or index finger, instead of rotating the entire handleassembly. The axial rotation knob 24 has the tapered or conical cavityin which the proximal bendable member is mounted for motion with theknob. In order to maintain maximum control of the distal tool, theproximal bendable member is disposed at least partially within theconical cavity in the axial rotation knob 24 thereby minimizing thedistance between the knob and the user's hand. If the proximal bendablemember is situated too far from the handle this can give the user afeeling of floppiness in the use of the instrument. Accordingly, bydisposing the proximal bendable member at least partially within theknob one minimizes this sloppiness. This placement also enables theinstrument shaft to be closer to the user's hand. There may be instanceswhere the user wants to control the instrument by directly applyingpressure to the instrument shaft rather than through the bendablemember. In such case the user would lean their index finger on thefinger support sleeve 26 which would allow the user to apply forcedirectly on the instrument shaft.

As indicted hereinbefore and as depicted in FIG. 4 the surgeon is ableto roll the instrument's tool about its longitudinal axis at anyorientation (bent position) simply by rolling the axial rotation knob24. FIGS. 25-28 illustrate the sequential positions of the rotation knob24 and the corresponding orientation of the tool 16, rotated about thetool axis P. The direction or orientation of the bend (angle B2) of thedistal bendable member, relative to the shaft axis Z, is not effected bythe rotation at the knob 24. As can be seen from the sequence of FIGS.25-28, this rotation simply rotates the distal motion member and tool onits own distal motion axis P without changing the orientation of thetool. The orientation is only affected by the bending action.

The instrument schematically illustrated in FIGS. 25-28 may be the sameinstrument as described hereinbefore in FIGS. 1-24. In FIGS. 25-28 thebendable members are considered as being maintained in a particularposition corresponding to the same respective proximal and distalbendable member angles B1 and B2. The respective FIGS. 25-28 show therotation knob 24 in successive 90 degree positions and the manner inwhich the motion imparted to the rotation knob is transferred to thedistal bendable member and tool. From position to position theorientation of the tool along axis P is maintained the same. In oneexample in FIGS. 25-28 the angle B1 may be 25 degrees and the angle B2may be 35 degrees. The angle B1 is measured between axis T of the handleand the main instrument axis Z, while angle B2 is measured between thedistal tool axis P and the axis Z.

The control between the proximal bendable or flexible member 18 and thedistal bendable or flexible member 20 is carried out by means of theflex control cables 100. There are four such cables identified as cables100A, 100B, 100C and 100D. At the distal end of these cables, as hasbeen described hereinbefore, the cables connect to the anchors 56 and 58at the jaws. Cables 100 are retained at their proximal ends by cable endlugs 102. Four springs 104 are retained between these end lugs 102 and awall of the rotation knob 24. FIGS. 25-28 illustrate the cable ends bythe proximal ends 100A′, 100B′, 100C′ and 100D′, and by the distal ends100A″, 100B″, 100C″ and 100D″.

FIG. 25 also depicts the rolling motion that can be carried out with theinstrument of the present invention. This occurs by virtue of therotation of the rotation knob 24 relative to the handle 12 about axis T.This is illustrated in FIG. 25 by the circular arrow R1. When therotation knob 24 is rotated, in either direction, this causes acorresponding rotation of the instrument shaft 14 about axis Z. This isdepicted in FIG. 25 by the rotational arrow R2. This same motion alsocauses a rotation of the end effector 16 about axis P as illustrated bythe rotational arrow R3. FIGS. 25-28 also show a proximal coordinate atQ at the proximal cable ends and a distal coordinate at U at the distalcable ends. The directional arrows N(north); W(west); S(south) andE(east) depict the sequential rotation of the rotation knob 24 in thesecoordinate systems, and as relates to the state of the cabling betweenthe proximal and distal members of the instrument.

FIG. 25 depicts an initial position of the instrument with the bendablemembers 18 and 20 in a certain position. For the sake of clarity indescribing the operation the bendable members are considered as beingmaintained in the same bent condition and only the knob rotation isconsidered as changing during the sequence from FIG. 25 to FIG. 28. Ofcourse, in practice the instrument functions with the ability to bend inany direction and to roll the tool about axis P through any angle inperforming an actual medical procedure. Also, even though only 90 degreeintervals are described in relationship to FIGS. 25-28, it is understoodthat the same distal rotation about axis P occurs for all intermediatepositions. Also, four cables are depicted in the illustratedembodiments, however, fewer or more then four may be used

In FIG. 25 the handle 12, via proximal bendable member 18, is showntilted along axis T at an angle B1. This tilting or bending may beconsidered as in the plane of the paper. By means of the cabling 100this action causes a corresponding bend at the distal bendable member 20to a position wherein the tip is directed along axis P and at an angleB2. This distal bending is also considered as in the plane of the paper.The cabling 100 is depicted wherein two of the cables are considered intension and the other two are relaxed. In the position depicted therotation knob 24 may be considered as in the initial position N. In thatposition the cables 100A and 100B are in their relaxed state whilecables 100C and 100D are in their tensioned state. This causes a bendingdown of the instrument tip in response to the handle being bent orpivoted upwardly, as shown.

The rotation knob 24 is then rotated through 90 degrees to the positionW depicted in FIG. 26. This rotates the position of the cables so thatthe cables 100B and 100C are in their relaxed state while cables 100Aand 100D are in their tensioned state. This action maintains the sameorientation of the tool 16 along axis P, but rotates the distal bendablemember and tool about the axis P. Both ends of the instrument aremaintained in the plane of the paper. The rotation of the tool isdepicted by the jaws having been rotated through 90 degrees, as can beseen by a comparison of FIGS. 25 and 26. The orientation along axis P ismaintained.

The rotation knob 24 is then rotated through 90 degrees to the positionS depicted in FIG. 27. This rotates the position of the cables so thatthe cables 100C and 100D are in their relaxed state while cables 100Aand 100B are in their tensioned state. This action maintains the sameorientation of the tool 16 along axis P, but rotates the tool about theaxis P. Both ends of the instrument are maintained in the plane of thepaper. The rotation of the tool is depicted by the jaws having beenrotated through 90 degrees, as can be seen by a comparison of FIGS. 26and 27. The orientation along axis P is maintained.

The rotation knob 24 is then rotated through 90 degrees to the positionE depicted in FIG. 28. This rotates the position of the cables so thatthe cables 100A and 100D are in their relaxed state while cables 100Band 100C are in their tensioned state. This action maintains the sameorientation of the tool 16 along axis P, but rotates the tool about theaxis P. Both ends of the instrument are maintained in the plane of thepaper. The rotation of the tool is depicted by the jaws having beenrotated through 90 degrees, as can be seen by a comparison of FIGS. 27and 28. The orientation along axis P is maintained.

In the disclosed embodiments the rotation knob is illustrated as a knobhaving indentations for the finger or fingers. In alternate embodimentsof the invention the rotation function may be performed by other meanssuch as a rotation wheel or a rotatable lever.

Still another aspect of the surgical instrument of the present inventionis the ability to adapt the instrument to a wide variety of medicalprocedure. This includes, but is not limited to, access to a body cavitysuch as through an incision or intraluminal use such as through anatural body aperture to a body lumen. The introduction of the surgicalinstrument into the anatomy may also be by percutaneous or surgicalaccess to a lumen, cavity or vessel, or by introduction through anatural orifice in the anatomy.

There are several improvements brought forth by employing bendablesections for the motion members particularly as opposed to othermechanisms such as pivotal joints or ball-and-socket joints.

A first important attribute of a bendable member is in its inherentlateral (bending) stiffness, especially when used for the proximalhandle motion member. In a jointed arrangement the proximal joint issituated between the elongated shaft and the control handle, togetherwith the fulcrum at the incision. This behaves as a “double joint” andthe instrument may have a serious tool stability issue if the joint is“free” to move. Suppose the operating surgeon slightly moves his/herwrist while holding the control handle of the instrument. If the jointis “free” to move without providing substantial support resistance, dueto the fulcrum effect of the long elongated shaft passing through theincision, it will result in substantial, unintended swinging of the toolend of the instrument in opposite direction. In a typical laparoscopicor endoscopic procedure where the operating field is small, suchinstability of the tool will render the tool potentially dangerous andunusable. Unlike the pivotal or ball-and-socket joints that are “free”to move, a bendable member has inherent stiffness which acts to providenecessary support for stabilizing the operator hand's wrist movement,which in turn stabilizes the tool motion. By varying the material andgeometry of the bendable member, the appropriate level of stabilitycould be selected.

A second important attribute of the bendable member, especially forbending in two degrees of freedom, is its uniformity in bending. Becausethe bendable member can bend in any direction uniformly, it has noinherent singularity, and as the result, the operator can produceuniform rolling motion of the tool, an important motion for tasks suchas suturing, simply by rolling the control handle. On the other hand, ifthe motion members are comprised of series of pivotal joints, not onlymay it bind due to singularities, but the rolling of the control handlewill result in unwanted side motion of the tool as well, affecting itsusability for surgical procedure.

A third attribute of the bendable member is its ability to transmitsubstantial torque axially. By selecting appropriate material andgeometry, the bendable member can be constructed to transmit torqueaxially necessary to perform surgical procedure. On the other hand, themotion member comprised of ball-and-socket joints will not be able totransmit the necessary torque from the handle to the tool end.

A fourth attribute of the bendable member is that it has no sharpbending point, location or pivot and thus this results in an increasedlife and higher performance. Either pivotal or ball-and-socket joints onthe other hand have sharp corners which can increase friction, reducelife and decrease performance of the tool actuation push rod passingthrough.

A fifth attribute of the bendable member is in the reduction ofmanufacturing cost. The bendable motion member can be injection moldedas a single body, thus significantly reducing the cost. Pivotal orball-and-socket joints are comprised of more parts and this results in ahigher manufacturing cost.

Lastly, a sixth attribute of the bendable member is that it can beeasily customized. By varying the stiffness at different points of thebendable member, one can optimize its bending shape for specificapplications.

While this invention has been particularly shown and described withreferences to preferred embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims. For example, the embodimentsdescribed herein have primarily used four control cables for providingall direction motion of the motion members. In alternate embodimentsfewer or greater numbers of cables may be provided. In a most simplifiedversion only two cables are used to provide single DOF action at thebendable motion member. Also, the disclosed embodiment uses a handlethat is essentially in line with the instrument shaft. In an alternateembodiment of the invention the handle can be off axis or at an angle tothe instrument shaft in the rest position of the instrument.

1. A surgical instrument comprising: an elongated instrument shafthaving proximal and distal ends; a tool disposed from the distal end ofthe instrument shaft and supported extending along a distal tool axis; acontrol handle disposed from the proximal end of the instrument shaft; adistal bendable member for coupling the distal end of said elongatedinstrument shaft to said tool; a proximal bendable member for couplingthe proximal end of said elongated instrument shaft to said handle;actuation means extending between said distal and proximal bendablemembers for coupling motion of said proximal motion member to saiddistal motion member for controlling the positioning of said tool; and arotation knob adjacent the control handle and rotatable relative to thecontrol handle for causing a corresponding rotation of the tool aboutsaid distal tool axis.
 2. The surgical instrument of claim 1 whereinsaid proximal bendable member supports said rotation knob so that anyrotation imparted to said knob causes a corresponding rotation of saidproximal bendable member.
 3. The surgical instrument of claim 2 whereinsaid knob has a cavity for receiving at least a portion of said proximalbendable member.
 4. The surgical instrument of claim 1 wherein saidproximal bendable member is bendable into a curved configuration and isfixedly secured with said rotation knob.
 5. The surgical instrument ofclaim 1 wherein both said bendable members are bendable into a curvedconfiguration and any rotation of said rotation knob causes acorresponding rotation of said bendable members, instrument shaft andtool.
 6. The instrument of claim 1 wherein said rotation know has acavity for receiving at least a portion of said proximal bendable membertherein.
 7. The instrument of claim 6 wherein at least a portion of saidrotation know is received by said handle in an open end of said controlhandle.
 8. The instrument of claim 1 including an actuating cable forthe tool and a control mechanism mounted from the control handle forcontrolling the actuating cable.
 9. The instrument of claim 8 whereinthe control mechanism includes a pair of springs and a slider forsupporting one of the springs.
 10. The instrument of claim 1 whereinsaid actuating elements include multiple cables each having proximal anddistal cable ends, the proximal cable ends terminating at the rotationknow and the distal cable ends terminating at the tool.
 11. The surgicalinstrument of claim 1 wherein said tool is supported from said distalbendable member extending along a distal tool axis and said rotationknob causes a rotation of said tool about said distal tool axis.
 12. Thesurgical instrument of claim 11 wherein the rotation of said rotationknob rotates the instrument shaft and distal bendable member, rotatingthe tool about the distal tool axis while maintaining the orientation ofthe tool as independently controlled from said bendable members.
 13. Amanually operated medical instrument having an instrument shaft thatcouples with an operating handle at a proximal end thereof and a tool ata distal end thereof, further comprising a proximal bendable member atthe proximal end of the instrument shaft that is bendable into a curvedconfiguration, a distal bendable member at the distal end of theinstrument shaft that is bendable into a curved configuration, saiddistal bendable member having a different transverse cross-sectionaldimension than that of said proximal bendable member, and one or moreactuating elements intercoupling the proximal and distal bendablemembers responsive to a manually initiated bending at the proximalbendable member to cause a corresponding bending into a curvedconfiguration of the distal bendable member so as to control, via thehandle, the positioning of the tool.
 14. The instrument of claim 13wherein the bendable members are bendable in all directions.
 15. Theinstrument of claim 13 wherein the bendable members are bendable in anydirection and the distal bendable member has a smaller transversecross-sectional dimension than that of said proximal bendable member.16. The instrument of claim 13 wherein the proximal bendable member ismanipulated in any direction do that the distal bendable member iscontrolled in three dimensions.
 17. The instrument of claim 13 furtherincluding a rotation knob disposed between said handle and proximalbendable member.
 18. The instrument of claim 17 wherein said rotationknob is supported to rotate the proximal bendable member therewith. 19.The instrument of claim 18 wherein rotation of the rotation knobcontrols the tool for corresponding rotation about a tool axis.
 20. Theinstrument of claim 18 wherein said tool is disposed from said distalbendable member along a longitudinal distal tool axis, the rotation ofsaid rotation knob causing a corresponding rotation of said tool aboutsaid distal tool axis.
 21. The instrument of claim 18 wherein said oneor more actuating elements comprises a set of actuation cables andwherein at least one of said set is in tension while at least anotherone thereof is in relaxation.
 22. The instrument of claim 21 includingfour cables disposed at 90 degree intervals about the instrument shaftwith two in tension and two in relaxation during a bending.
 23. Theinstrument of claim 17 wherein the instrument shaft comprises anelongated instrument shaft extending along a longitudinal axis andwherein the distal bendable member is disposed in-line with theelongated instrument shaft coupling a distal end of said elongatedinstrument shaft to said tool and wherein the proximal bendable memberis disposed in line with the elongated instrument shaft coupling aproximal end of said elongated instrument shaft via said rotation knobto said handle.
 24. The instrument of claim 13 wherein said actuatingelements include multiple cables each having proximal and distal cableends, the proximal cable ends terminating adjacent a proximal end of theproximal bendable member and the distal cable ends terminating adjacenta distal end of the distal bendable member.
 25. The instrument of claim24 further including a rotation knob disposed between said handle andproximal bendable member and wherein said rotation knob has a cavity forreceiving at least a portion of said proximal bendable member thereinand at least a portion of said rotation knob is received by said handlein an open end of said handle.
 26. The instrument of claim 25 whereinsaid rotation knob has said proximal bendable member supported thereinand in a fixed linear, but rotational position with said proximalbendable member.
 27. The instrument of claim 13 including an actuatingcable for the tool and a control lever mounted from the operating handlefor controlling the actuating cable.
 28. The instrument of claim 27wherein the control lever is pivotally mounted from the operating handleand further including biasing means in the handle for returning the toolto an open position.
 29. The instrument of claim 13 including a rotationknob having a cavity for receiving at least a portion of said proximalbending member therein.
 30. The instrument of claim 29 wherein at leasta portion of said rotation knob is received by said operating handle inan open end of said handle.
 31. The instrument of claim 13 including anactuating cable for the tool and a control mechanism mounted from theoperating handle for controlling the actuating cable.
 32. The instrumentof claim 31 wherein the control mechanism includes a pair of springs anda slider for supporting one of the springs.
 33. The instrument of claim13 including a rotation knob and wherein said actuating elements includemultiple cables each having proximal and distal cable ends, the proximalcable ends terminating at the rotation knob and the distal cable endsterminating at the tool.
 34. The surgical instrument of claim 13 whereinsaid tool is supported from said distal bendable member extending alonga distal tool axis and including a rotation knob that causes a rotationof said tool about said distal tool axis.
 35. The surgical instrument ofclaim 34 wherein the rotation knob rotates the instrument shaft anddistal bendable member, rotating the tool about the distal tool axiswhile maintaining the orientation of the tool as independentlycontrolled from said bendable members.
 36. A surgical instrumentcomprising: an elongated instrument shaft having proximal and distalends; a working member disposed from the distal end of the instrumentshaft; a control handle disposed from the proximal end of the instrumentshaft; a distal bendable member capable of bending into a curvedconfiguration; said working member being coupled to the distal end ofsaid elongated instrument shaft via said distal bendable member; aproximal bendable member capable of bending into a curved configuration;said control handle coupled to the proximal end of said elongatedinstrument shaft via a proximal bendable member; a manually rotatablemember arranged adjacent the control handle and between the controlhandle and proximal bendable member; said manually rotatable memberadapted to be manually rotated to, in turn, rotate the proximal bendablemember, instrument shaft, distal bendable member and working memberrelative to said control handle; and an actuation element extendingbetween said distal and proximal bendable members whereby any deflectionof said control handle with respect to said elongated instrument shaftcauses a bending of said proximal bendable member and a correspondingbending of said distal bendable member for control of said workingmember.
 37. The surgical instrument of claim 36 wherein said manuallyrotatable member comprises a rotation knob having a cavity for receivingat least a portion of said proximal bendable member therein and at leasta portion of said rotation knob is received by said handle in an openend of said handle, said rotation knob having said proximal bendablemember supported therein and in a fixed relative rotation with respectto said proximal bendable member.
 38. The surgical instrument of claim36 wherein said working member comprises a tool that is supported fromsaid distal bendable member extending along a distal tool axis and saidrotatable member comprises a rotation knob, the rotation of saidrotation knob causing a rotation of said working member about saiddistal tool axis.
 39. The surgical instrument of claim 38 wherein therotation of said rotation knob rotates the instrument shaft and distalbendable member, rotating the tool about the distal tool axis whilemaintaining the orientation of the tool as independently controlled fromsaid bendable members.
 40. The instrument of claim 36 wherein saidactuation element includes multiple cables each having proximal anddistal cable ends, the proximal cable ends terminating adjacent aproximal end of the proximal bendable member and the distal cable endsterminating adjacent a distal end of the distal bending member.
 41. Theinstrument of claim 40 wherein the manually rotatable member has acavity for receiving at least a portion of said proximal bendable membertherein and at least a portion of said manually rotatable member isreceived by said control handle in an open end of said control handle.42. The instrument of claim 41 wherein said manually rotatable memberhas said proximal bendable member supported therein and in a fixedlinear, but rotational position with respect to said proximal bendablemember.
 43. The instrument of claim 36 including an actuating cable forthe working member and a control lever mounted from the control handlefor controlling the actuating cable.
 44. The instrument of claim 43wherein the control lever is pivotally mounted from the control handleand further including biasing means in the control handle for returningthe working member to an open position.
 45. The instrument of claim 36wherein the manually rotatable member has a cavity for receiving atleast a portion of said proximal bendable member therein.
 46. Theinstrument of claim 45 wherein at least a portion of said manuallyrotatable member is received by said control handle in an open end ofsaid handle.
 47. The instrument of claim 36 including an actuating cablefor the working member and a control mechanism mounted from the controlhandle for controlling the actuating cable.
 48. The instrument of claim47 wherein the control mechanism includes a pair of springs and a sliderfor supporting one of the springs.
 49. The instrument of claim 36wherein said actuating elements include multiple cables each havingproximal and distal cable ends, the proximal cable ends terminating atthe manually rotatable member and the distal cable ends terminating atthe working member.
 50. A manually operated medical instrument having aninstrument shaft that couples with an operating handle at a proximal endthereof and a tool at a distal end thereof, further comprising aproximal bendable member at the proximal end of the instrument shaftthat is bendable into a curved configuration, a distal motion member atthe distal end of the instrument shaft that is deflectable, one or moreactuating elements intercoupling the proximal bendable member and thedistal motion member responsive to a manually initiated bending at theproximal bendable member to cause a corresponding deflection of thedistal motion member so as to control, via the handle, the positioningof the tool and a rotation knob disposed between said hand and proximalbendable member for controlling the rotation of the tool.
 51. Theinstrument of claim 50 wherein the instrument shaft comprises anelongated instrument shaft extending along a longitudinal axis andwherein the distal motion member is disposed in-line with the elongatedinstrument shaft coupling a distal end of said elongated instrumentshaft to said tool and wherein the proximal bendable member is disposedin line with the elongated instrument shaft coupling a proximal end ofsaid elongated instrument shaft via said rotation knob to said handle.52. The instrument of claim 50 wherein said rotation knob has a cavityfor receiving at least a portion of said proximal bendable membertherein and at least a portion of said rotation knob is received by saidhandle in an open end of said handle, said rotation knob having saidproximal bendable member supported therein and in a fixed linearposition with said proximal bendable member.
 53. The instrument of claim50 wherein said tool is supported from said distal motion memberextending along a distal tool axis and said rotation knob causing arotation of said tool about said distal tool axis.
 54. The instrument ofclaim 53 wherein the rotation of said rotation knob rotates theinstrument shaft and distal motion member, rotating the tool about thedistal tool axis while maintaining the orientation of the tool asindependently controlled from said proximal bendable member.
 55. Theinstrument of claim 50 wherein said rotation knob is supported to rotatethe proximal bendable member therewith, said one or more actuatingelements comprises a set of actuation cables and wherein at least one ofsaid set is in tension while at least another one thereof is inrelaxation.
 56. The instrument of claim 55 including four cablesdisposed at 90 degree intervals about the instrument shaft with two intension and two in relaxation during a bending.
 57. The instrument ofclaim 50 wherein said distal motion member comprises a distal bendablemember and said distal bendable member has a different transversecross-sectional dimension than that of said proximal bendable member.58. The instrument of claim 50 wherein said distal motion membercomprises a distal bendable member, both said bendable members arebendable into a curved configuration and any rotation of said rotationknob causes a corresponding concurrent rotation of said proximalbendable member, instrument shaft, distal bendable member and tool. 59.The instrument of claim 50 wherein said rotation knob has a cavity forreceiving at least a portion of said proximal bendable member therein.60. The instrument of claim 59 wherein at least a portion of saidrotation knob is received by said handle in an open end of said handle.61. The instrument of claim 60 wherein the distal motion member is adistal bendable member.
 62. The instrument of claim 50 including anactuating cable for the tool and a control mechanism mounted from theoperating handle for controlling the actuating cable.
 63. The instrumentof claim 62 wherein the control mechanism includes a pair of springs anda slider for supporting one of the springs.
 64. The instrument of claim50 wherein said actuating elements include multiple cables each havingproximal and distal cable ends, the proximal cable ends terminating atthe rotation knob and the distal cable ends terminating at the tool.